- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06866054
Serratus Posterior Superior Intercostal Plane Block for Arthroscopic Shoulder Surgery
Evaluation of the Effectiveness of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia Management in Patients Undergoing Arthroscopic Shoulder Surgery
Postoperative pain is a significant problem in patients undergoing arthroscopic shoulder surgery. This situation disrupts the patient's comfort and affects the functional outcome after surgery by preventing early rehabilitation. Various methods are used for postoperative pain control. Intravenous opioid agents are one of the most commonly used analgesic techniques. However, opioids can cause undesirable side effects such as respiratory depression, sedation, constipation, allergic reactions, nausea, and vomiting. Therefore, alternative techniques are needed to reduce opioid use.
Serratus posterior superior interfascial plane block (SPSIPB) is a novel interfascial plane block described by Tulgar et al in 2023. It is based on injection into the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in cases such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. It has been reported that SPSIPB provides effective shoulder analgesia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain is a significant problem in patients undergoing arthroscopic shoulder surgery. This situation disrupts the patient's comfort, prevents early rehabilitation, and affects the functional outcome after surgery. Various methods are used for postoperative pain control. Intravenous opioid agents are one of the most commonly used analgesic techniques. However, opioids can cause undesirable side effects such as respiratory depression, sedation, constipation, allergic reactions, nausea, and vomiting. Therefore, alternative techniques are needed to reduce opioid use. Regional techniques can be used for postoperative pain treatment following arthroscopic shoulder surgery. Ultrasound (US)-guided serratus posterior superior block (SPSIPB) is a novel interfascial plane block described by Tulgar et al in 2023. It is based on the principle of injection into the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in cases such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. Analgesia is provided by blocking these nerves with the SPS block. Tulgar et al. reported in their cadaver study that the spread of the serratus posterior superior interfascial plane block; staining in the superficial fascia of the trapezius muscle was observed only on the left side at the 7-10th intercostal levels, but not on the right. There was significant staining deep in the trapezius muscle on both sides. Both the surface and the skin of the rhomboid major were clearly stained, while only the skin of the rhomboid minor was stained; SPSP block will provide successful analgesia in procedures involving the thoracic region such as breast surgery, thoracic surgery, and shoulder surgery.
In this study, the investigators aim to evaluate the analgesic efficacy of SPSIPB by comparing the control group in patients who underwent arthroscopic shoulder surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bora Bilal, Assoc Prof, MD
- Phone Number: +905052354430
- Email: borabilal@gmail.com
Study Contact Backup
- Name: Bahadir Ciftci, Assoc Prof, MD
- Email: bciftci@medipol.edu.tr
Study Locations
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-
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Kahramanmaraş, Turkey, 46200
- Recruiting
- KSU Faculty of Medicine Research Hospital
-
Contact:
- Bora Bilal
- Phone Number: 03443003245
- Email: bbilal@ksu.edu.tr
-
-
Bagcilar
-
Istanbul, Bagcilar, Turkey, 34000
- Not yet recruiting
- İstanbul Medipol University
-
Contact:
- Bahadir Ciftci, Assoc Prof, MD
- Email: bciftci@medipol.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for arthroscopic shoulder surgery under general anesthesia
Exclusion Criteria:
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- patients who do not accept the procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group SPSIPB = SPSIPB group
SPSIPB will be performed
|
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period.
A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit.
If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.
Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used.
The procedure will be performed with the patient in the lateral decubitus position.
After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib.
The in-plane technique will be used.
The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib.
The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle.
After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used.
|
|
Other: Group Control
Conventional analgesia management will be performed
|
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period.
A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit.
If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.
Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption (Fentanyl PCA)
Time Frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
|
The primary aim is to compare postoperative opioid consumption from the PCA device.
|
Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Need for rescue analgesia (meperidine)
Time Frame: Postoperative 24 hours period
|
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
|
Postoperative 24 hours period
|
|
Pain scores (Numerical rating scale-NRS)
Time Frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
|
The secondary aim is to compare NRS at the postoperative 24 h.
Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt).
The NRS scores will be recorded
|
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
|
|
Adverse events
Time Frame: Postoperative 24 hours period
|
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use
|
Postoperative 24 hours period
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Nov;89(11):1054-1056. doi: 10.23736/S0375-9393.23.17432-3. Epub 2023 Jun 1. No abstract available.
- Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block: novel thoracic paraspinal block for thoracoscopic and shoulder surgery. Minerva Anestesiol. 2024 Apr;90(4):345-347. doi: 10.23736/S0375-9393.23.17827-8. Epub 2024 Jan 19. No abstract available.
- Kulturoglu G, Altinsoy S, Ozguner Y, Cataroglu CK. Novel Serratus Posterior Superior Intercostal Plane Block Provided Satisfactory Analgesia after Breast Cancer Surgery: Two Case Reports. Turk J Anaesthesiol Reanim. 2024 Feb 28;52(1):33-35. doi: 10.4274/TJAR.2024.231431.
- Turan EI, Isik S, Baydemir AE, Sahin AS. Serratus posterior superior intercostal plane block for postoperative analgesia in clavicle surgeries: new indications for a novel block. Minerva Anestesiol. 2024 Nov;90(11):1058-1060. doi: 10.23736/S0375-9393.24.18275-2. Epub 2024 Aug 5. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-744
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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